FDA Halts Kezar Lupus Trial Following Patient Deaths Report

Kezar Life Sciences’ promising autoimmune drug candidate, zetomipzomib, has encountered a significant setback as the FDA has placed it on hold. This decision follows the recent announcement by the company that four patients had died in a Phase 2b trial for lupus nephritis. These tragic events occurred in the Philippines and Argentina, with the patients having received treatment with zetomipzomib. According to Kezar, three of the deceased patients exhibited "a common pattern of symptoms and proximity to dosing." Additionally, other patients who had a "similar proximity to dosing" experienced severe but non-fatal side effects.

Kezar Life Sciences has stated that they anticipate receiving an update from the FDA within 30 days. Chris Kirk, Kezar's CEO, expressed the company's unwavering commitment to patient safety and assured that they are thoroughly investigating these incidents to continue the development of zetomipzomib. 

Despite this hold, a separate Phase 2a trial of zetomipzomib for autoimmune hepatitis is proceeding as planned, with no grade 4 or 5 adverse events reported. The drug, which is a selective immunoproteasome inhibitor, has been highlighted by Kezar as a potential pipeline in a pill for various autoimmune conditions.

Zetomipzomib is one of only two drugs in Kezar's developmental pipeline. The other drug is KZR-261, which is in a Phase 1 trial targeting advanced solid tumors. However, in August, Kezar halted enrollment in the KZR-261 study after researchers observed no objective responses. This strategic shift directed more resources towards the development of zetomipzomib.

Facing financial pressures, Kezar made significant organizational changes in October. The company laid off 41% of its workforce and ceased all preclinical research and development to reduce costs and better allocate funds towards its clinical-stage programs. As of the end of June, Kezar reported having $164 million in cash, cash equivalents, and marketable securities.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!